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Wednesday, 30 October 2024 19:41

ISRAEL MINISTRY OF HEALTH CERTIFIES THAT BONOFILL AND MESENCURE ARE PRODUCED IN COMPLIANCE WITH GOOD MANUFACTURING PRACTICES, AS RECOMMENDED BY THE WORLD HEALTH ORGANIZATION

Bonus Biogroup is pleased to announce that on October 29, 2024, the Israel Ministry of Health (MOH) issued a certification that the Company's two products, BonoFill—a live human bone graft—and the cellular therapy MesenCure, are manufactured by the Company through an industry-standard process conducted under Good Manufacturing Practices (GMP) for phase III clinical trials.

Additionally, the MOH issued a certificate of accreditation confirming that the industrial production facilities for each of the two products, BonoFill and MesenCure, located at Bonus Biogroup Center in MATAM Advanced Technologies Park, Haifa, meet GMP requirements as recommended by the World Health Organization (WHO) [1] and under Israeli laws and regulations.

These GMP certifications demonstrate the high quality of the Company's two products, BonoFill and MesenCure, which are in advanced clinical development, as well as the Company's robust preparedness level for conducting phase III clinical trials.

The Ministry of Health also approved advanced testing methods developed by the Company and authorized the internal execution of critical quality assessments for the Company's products. Compared to the four days previously required in external laboratories, these tests are now conducted in just one day at the Company's production facilities. This development strengthens the Company's operational independence, reduces production time and costs, and enhances quality control. Furthermore, the shortened production timeline is expected to streamline the Company's management of supply chains for advanced clinical trials planned internationally.

In the United States, a phase III clinical trial of MesenCure is planned to test the efficacy and safety of this next-generation cell therapy in severely ill patients suffering from respiratory distress caused by viral, bacterial, or chemical pneumonia or other forms of acute lung injury. The target market for this indication is estimated at $16.5 billion annually across the primary territories targeted by the Company [2]. This phase III trial follows a phase II trial where MesenCure demonstrated a 68% reduction in the mortality rate among severely ill patients, alongside a substantial reduction of approximately ten days in hospital stay.

Additionally, the first phase III clinical trial for BonoFill is planned in the United States to test the efficacy and safety of BonoFill for regenerating and rehabilitating facial bone deficiencies. This follows the complete success achieved in bone reconstruction with BonoFill in 90% of transplants during a phase II clinical trial [3].

The Company estimates that by 2030, the U.S. facial bone graft market could reach $10 billion for this indication alone, with potential expansion to around $25 billion through applications for limb bone regeneration and rehabilitation, which are currently being investigated in another phase II clinical trial [4].

Dr. Shai Meretzki, CEO of Bonus Biogroup, stated: "The certification confirming that the Company's two products, BonoFill and MesenCure, are manufactured through GMP-compliant processes and facilities in accordance with WHO recommendations marks a critical strategic milestone, positioning Bonus Biogroup at the forefront of cell therapy and tissue engineering worldwide. Beyond validating the high quality of our products, these certifications demonstrate our readiness for industrial-scale production aimed at multi-billion-dollar markets with minimal competition. Each of our products—BonoFill, for treating bone deficiencies, and MesenCure, for respiratory distress—offers an innovative therapeutic approach poised to revolutionize advanced therapies and deliver high-quality, life-saving solutions for millions of patients globally."

The certified production facilities in Haifa include clean rooms with a sterile Grade A environment for growing cells and tissues, meeting strict GMP standards. These facilities are furnished with advanced equipment and control systems for continuous monitoring of all production stages and infrastructure for storing cells and tissues, assembling, and packaging products. All elements are designed to ensure compliance with stringent regulatory requirements for cell-based products intended for human use, as required by regulatory authorities in the US (FDA), Europe (EMA), and Israel.

Bonus Biogroup's production capacity at its certified facilities for BonoFill and MesenCure could allow the Company, in due course, to expand into industrial-scale production of both products beyond the quantities required for clinical trials in Israel and abroad, potentially enabling the commencement of commercial production and marketing. The production facilities are designed to integrate automation and reduce manual involvement in the manufacturing processes to enhance productivity and improve product consistency, quality, and safety, along with achieving savings in labor and additional costs to increase the Company's profitability.

About Bonus Biogroup

Bonus Biogroup Ltd. is a clinical-stage biotechnology company dedicated to developing advanced therapies in tissue regeneration and biotech products using tissue engineering and cell therapy. The Company currently has two products in clinical development: BonoFill™, a live tissue-engineered human bone graft intended for bone tissue regeneration and rehabilitation, and MesenCure, a cell therapy designed to treat inflammation and tissue damage, including pneumonia and respiratory distress. Bonus Biogroup also maintains a variety of technologies and products in the preclinical development phase.

The development of these products involves the application of unique technologies and knowledge proprietary to Bonus Biogroup. The Company's robust intellectual property portfolio includes six families of patents and patent applications, comprised of thirty-nine approved patents and eleven patent applications, spanning numerous countries worldwide.

About BonoFill™ – A Live Human Bone Graft

Bone deficiencies can result from a wide variety of causes, including aging, infections, arthritis accompanied by bone loss, various types of trauma (accidents or falls), and cancerous tumors. Bonus Biogroup develops live grafts of injectable human bone based on cells sampled from the patient to reduce the risk of rejection. The cells sampled from adipose tissue are grown in a bioreactor on three-dimensional scaffolds for 2-3 weeks. This process yields a large amount of bone tissue, sufficient to create a live human bone graft that matches the patient's existing bone deficiency.

Growing bone grafts outside the patient's body allows bone grafts to be made upon request. These grafts can be effectively used for various medical needs, including oral and maxillofacial surgery, skull surgery, orthopedic surgery, and plastic surgery in cases lacking bone tissue. The company has completed a Phase II clinical trial to treat bone deficiencies in the upper or lower jaw bones using BonoFill™. The results indicate that BonoFill™ achieved complete success in bone reconstruction in 90% of the transplants conducted, with a reduction of approximately half to two-thirds of the healing period, enabling patients to return to their regular routine within a relatively short time.

In addition to the Phase II clinical trial for treating facial bone deficiencies, the Company is conducting a Phase II multicenter clinical trial to treat limb bone defects in the hand or leg at six medical centers in Israel. In these two clinical trials, bone deficiencies were treated using BonoFill™.

The company estimates that within the applications in which it conducts clinical trials, BonoFill™ could be used to treat bone deficiencies for bone regeneration and reconstruction in a market that by 2030 is expected to reach $25 billion annually in the U.S. alone and potentially double that worldwide.

The existing alternative solutions to using a live human bone graft manufactured by Bonus Biogroup are autologous (self) bone transplantation—surgery to harvest bone from another part of the patient's body, sometimes together with its peripheral blood vessels, and implant it in the deficient area—or using a bone graft substitute, which in most cases does not lead to healing and does not allow the patient to return to normal functioning due to the lack of a natural connection between the artificial bone replacement and the human body.

Unlike autologous bone transplantation, which is the standard treatment today, the bone graft produced by Bonus Biogroup is not taken from the patient's body, avoiding an invasive, dangerous, and complex procedure. Instead, it is grown in the laboratory in the required volume to fully address the bone deficiency in the patient's body, based on a sample of the patient's cells, in a fast, safe, and patient- and health-system-friendly procedure. Additionally, the live implantation of human bone is done by injection, does not require a complex surgical procedure, and may expedite the patient's rehabilitation.

About the drug MesenCure

Bonus Biogroup has completed a Phase II clinical trial for treating pneumonia and life-teetering respiratory distress in severe COVID-19 patients using the cell therapy drug MesenCure [5]. Clinical trial results indicate that MesenCure reduced the mortality rate of severe COVID-19 patients by 68% compared to the control group, with the survival rate standing at 94% for the 50 severe patients treated with the drug.

MesenCure, comprised of professionalized mesenchymal cells, aims to treat inflammation and tissue damage, including pneumonia and respiratory distress caused by the coronavirus or other viruses, bacterial infections, or other sources of immune overactivity, inflammation, or tissue damage.

The drug's effectiveness is attributed to the professionalization of the comprising cells, which enhances their natural ability to heal inflammation and tissue damage. The cells constituting MesenCure also affect inflammation and promote tissue regeneration through various mechanisms, potentially offering a broader and superior effect on diverse populations suffering from inflammation and tissue damage from multiple causes compared to drugs with a single mechanism of action.

The company estimates that MesenCure™ may be used to treat respiratory distress in a market that by 2030 is expected to reach $23 billion annually in the U.S. alone and potentially double that worldwide.

Given the successful demonstration of MesenCure's effectiveness in treating acute respiratory distress in severe COVID-19 patients, the Company has broadened its efforts to investigate the potential efficacy of the drug and its derivatives in treating other indications such as cytokine release syndrome resulting from immunotherapy treatments to activate the immune system against cancer or from hematopoietic stem cell transplantation, as well as in tissue rehabilitation and healing.

Company Estimations Regarding Forward-Looking Statements

Bonus BioGroup's assessments regarding the medical effect and/or commercial potential of its products and/or the resulting economic opportunities, and the Company's ability to continue the process of their development, including conducting studies, and arriving at a product that can be medically applied in humans, for the duration and expected dates to perform any stage in any experiment and publish its results and obtain regulatory approvals for marketing the product, are forward-looking statements, as defined by the Securities Law of 1968, which are based on the Company's estimates and on the information in its possession at the time of reporting.

There is no certainty that these estimates will materialize, in whole or in part, among others, due to dependence on the actions of third parties, which are not under the Company's control, on the development of future cancer therapies, on future studies results, if any, due to the possibility of delay in obtaining approval from relevant authorities and/or change in the relevant conditions and/or feasibility tests that the Company may conduct and/or delay in performing studies and/or need to perform further experiments and/or failure of experiments and/or technological changes and/or the development and/or marketing of similar and/or more efficient competing products and/or the lack of resources and/or the realization of any of the risk factors associated with the research and/or studies and/or its results.

Sincerely,

Bonus Biogroup Ltd.

By: Yossi Rauch (Chairman of the Board) and Dr. Shai Meretzki (CEO and Director)

References

  1. WHO Health Products and Standards: Good Manufacturing Practices
  2. For more details, see Section 7.3.2 of Part A of the Company Annual Report for 2023, dated March 29, 2024 (reference 2024-01-034929), which is included herein by reference.
  3. For more details, see Immediate Report dated June 2, 2024 (reference 2024-01-055699), which is included herein by reference. Follow this link for English Convivence Translation.
  4. For more details, see Section 7.2.3 of Part A of the Company Annual Report for 2023, dated March 29, 2024 (reference 2024-01-034929), which is included herein by reference.
  5. For more details, see Section 14.2 of Part A of the Company Annual Report for 2023, dated March 29, 2024 (reference 2024-01-034929), which is included herein by reference.

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MAIL ICON  info@bonus-bio.com

MAIL ICON  +972 (0)73 206 7104

MAIL ICONMatam Advanced Technology
Park P.O.B 15143 Haifa 31905 Israel

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